Results: Patients had an average of 65 pack/year smoking history. An
average of 11 (range, 9-15) coils were placed per lobe (right upper
lobe=35, left upper lobe=19, right lower lobe=2, left lower lobe=4).
Mean follow-up duration was 12.6 months (±5.6 months). Post-treatment
forced expiratory volume in one second, residual volume and six-minute
walking distance values were improved with statistical significance.
Also, significant improvement was seen in quality of life, quantified
by modified Medical Research Council, chronic obstructive pulmonary
disease assessment test and Hospital Anxiety and Depression Scale
scores. While no immediate major postoperative complications
occurred, three patients developed chronic obstructive pulmonary
disease exacerbation, two developed pneumonia, and one developed
recurrence of previous neurologic disorder within 30 days.

Conclusion: Endobronchial coil administration provides lower
morbidity and mortality compared to lung volume reduction surgery as
well as significant improvement in pulmonary functions and quality of
life in selected patients with advanced emphysema.

Introduction

Chronic obstructive pulmonary disease (COPD)
is one of the leading causes of death worldwide.
With wider availability of healthcare and better
overall medical management, an increasing number of
patients are being followed-up for advanced COPD and
various other comorbidities.[1,2] Medical management
is effective for physiological relief and slowing down
maladaptive processes; however, there is a significant
subset of advanced emphysema patients who report
serious dyspnea despite optimal management. Due to
very stringent patient selection criteria, high morbidity
and limited availability of lung volume reduction
surgery (LVRS) and lung transplantation, newer
endoscopic treatment modalities are considered "to
go" options for palliation and stabilization of advanced
emphysema patients.[3,4]

Various endobronchial lung volume reduction
(ELVR) techniques have been proposed for
endobronchial treatment of advanced emphysema with
patient selection criteria mainly derived from LVRS,
reporting encouraging results, showing feasibility and
safety.[1,2,5-11] Most of the literature to date focuses on
endobronchial valves and coils.[6,8-10,12-17] Endobronchial
valves were the first reported and investigated solutions,
but their effectiveness can be hampered by collateral
ventilation of the targeted lobe and patient"s individual
anatomical limitations regarding large airways.[6,8,12]
Up to 67% of advanced emphysema patients are estimated
to have collateral ventilation of their targeted lobe,
leaving them largely unsuitable for endobronchial valves.

Endobronchial coils were first proposed in 2009,
as a solution for collateral ventilation problem in
endobronchial valves, with demonstrated clinical safety
and moderate clinical improvement.[1,18] Post-marketing
studies revealed encouraging results in small case
series and a few multi-institutional studies show
improved parameters including forced expiratory
volume in one second (FEV1), residual volume (RV),
six-minute walk distance (6MWD), modified Medical
Research Council (mMRC) dyspnea scores, COPD
Assessment Test (CAT) and Hospital Anxiety and
Depression Scale (HADS) scores and St. George's
Respiratory Questionnaire.[9,10,13-17] Long-term results
for most of those studies are expected. Therefore, in
this study, we aimed to present our experience with
endobronchial coils in patients who underwent ELVR
due to advanced emphysema.

Methods

Forty-six patients (45 males, 1 female; mean age
61.7±8 years; range, 43 to 80 years) who underwent
ELVR with coils (ELVR-C) were recorded in a prospective database between January 2012 and
December 2014 at Marmara University Pendik
Hospital, Thoracic Surgery Clinic. The study protocol
was approved by the Marmara University Medical
Faculty Ethics Committee (No. 09.2015.129). A written
informed consent was obtained from each patient. The
study was conducted in accordance with the principles
of the Declaration of Helsinki.

Advanced emphysema patients who were judged
as candidates were referred to our clinic by treating
physicians and were considered for inclusion. Patients
having both heterogeneous and homogeneous
emphysema were all included in the study. All
enrolled patients were in stage 3 or 4 of Global
Initiative for Chronic Obstructive Lung Disease,
and they were intended to be treated bilaterally.
The inclusion and exclusion criteria were similar to
those previously reported in the literature.[9,17] Briefly,
the inclusion criteria were: (i) post-bronchodilator
FEV1 of 15%-45%; (ii) RV >175%; (iii) 6MWT
>140 m; (iv) partial pressure of carbon dioxide
<55 mmHg; (v) bilateral emphysema as detected via
computed tomography; and (vi) smoking cessation
for >8 weeks prior to the primary intervention.
The exclusion criteria were: (i) post-bronchodilator
change in FEV1 >20%; (ii) frequent COPD
exacerbation episodes (>2 hospitalizations per year);
(iii) p ulmonary a rtery p ressure > 50 m mHg;
(iv) g iant bullae >1/3 o f a s ingle l ung v olume;
(v) bronchiectasis; (vi) lung cancer; or (vii) use of an
oral anticoagulant.

Endobronchial lung volume reduction with RePneu
coils (PneumRx Inc., Mountain View, California, USA)
was performed as previously described.[9,17] All patients
were intended to receive 10 coils in the target lobes of
each lung in two sequential sessions. Three sizes of
coils were available (100 mm, 125 mm, 150 mm) and
they were applied under general anesthesia through
the working channel of a flexible videobronchoscope
passed through the single lumen intubation tube, with
fluoroscopic guidance. All cannulated subsegmental
airways that were suitable for placement of a coil
were treated. The procedural duration, number of
coils used during the procedure, and postoperative
complications were recorded. Following recovery from
anesthesia, patients stayed in the hospital for one night
for observation, having a control chest X-ray to rule out
any pneumothorax.

Bilateral treatments were performed as sequential
procedures for safety reasons. Contralateral side was
treated one to three months after the initial procedure
if the patient was medically stable, compliant to the
therapy and follow-up (Figure 1).

Patients were followed-up at postoperative first
week, first month, sixth month and also referred for
further evaluation at our institution"s pulmonology
department with periodic phone calls. Follow-up
quality of life (QoL) questionnaires were gathered.

Statistical analysis
Data were analyzed using the IBM SPSS version
20.0 program (IBM Corp., Armonk, NY, USA).
Descriptive statistics were presented as mean and
standard deviation. Wilcoxon test and t-test for
independent samples were used for recurring data
(pre- and postoperative results).

Mean procedural duration was 58 min (range,
30-120 min). There was no adverse events during the
procedure, also no failure to extubate or unplanned
intubation during the hospital stay of the procedure.

A total number of 662 coils were placed in
60 procedures. In total, an average of 11 (9-15) coils
were inserted per lobe (right upper lobe=35, left upper lobe=19, right lower lobe=2, left lower lobe=4).
An average of 10.8 coils were placed per lobe on
the first procedure. For the second procedure, 11.4
coils were placed, showing a tendency for increased
number of airways successfully cannulated, while
this finding did not reach statistical significance. The
upper lobes were treated more than the lower lobes
(87.5%), while the right upper lobe comprised the
most preferred treatment site (58%). Post-treatment
FEV1, RV and 6MWD values were improved with
statistical significance (Table 2). There was also a
distinct beneficial quality of life effect, quantified
by mMRC, CAT and HADS scoring questionnaires
(Table 3). Those parameters were found to be changing
incrementally during the treatment periods for patients
who had bilateral procedures. None of the parameters
studied was significantly affected by the emphysema
type (homogeneous vs heterogeneous) or the laterality
of the procedure (for patient who had unilateral
treatment).

There was no 30 or 90-day mortality. Postoperative
complications were mild; one patient who had
preexisting epilepsy experienced a seizure, three COPD exacerbations and two pneumonia cases were
appropriately treated. One patient died at postoperative
sixth month due to immediate complications of
lung transplant. None of our patients developed
pneumothorax during or after the procedure. Two
patients died at seventh and eighth months due to COPD
exacerbation, pneumonia and sepsis. The last patient's
intensive care unit (ICU) stay was complicated due to
pneumothorax under mechanical ventilation, which
required a chest tube, draining massive air leak.

Discussion

Chronic obstructive lung disease is one of the
leading causes of death worldwide. Advances in
basic and clinical science lead to an increased
understanding of the pathophysiology of the
disease and maladaptive changes. Optimal medical
management leads to increased survival of COPD
patients but does little to alleviate the anatomic
changes, thus a decline in life expectancy and
QOL is inevitable. Lung volume reduction surgery
offers reasonable palliation of those changes with
acceptable mortality and morbidity but is only definitely effective in patients with upper lobe
predominant emphysema and low exercise capacity,
leaving a larger pool of patients without any option
besides medical management.[3,18] For patients with
advanced emphysema, there is a great need for a
modality of treatment that can significantly improve
QoL, without inducing significant morbidity and
mortality, and that is potentially available for the
majority of patients. Endobronchial lung volume
reduction is important in terms of providing improved
survival and better QoL for a larger patient pool
as it is minimally invasive and has a much better
complication profile when compared to LVRS.[1,5,11,18]

Endobronchial lung volume reduction with coils,
which is reported to be safe and associated with good
results, can be a preferred modality of treatment
for patients with advanced heterogeneous and
homogeneous emphysema.[9-11,17,18]

The beneficial effect of ELVR-C may arise from
the compression of the most damaged areas of the
lung due to advanced emphysema and expansion of the
relatively healthier parenchyma. Additional benefits
may include the reduction in dynamic airway collapse,
the reestablishment and improvement of elastic recoil,
and the increase in the compliance of the diaphragm
and the chest wall.[9,17]

In our study, ELVR-C treatment led to improvements
in pulmonary functions, exercise capacity and quality
of life at six months after the treatment. Post-treatment
FEV1, RV and 6MWD values were improved with
statistical significance, also the mMRC, CAT, and
HADS scores.

The RePneu Endobronchial Coils for the Treatment
of advanced emphysema with Hyperinflation (RESET)
study compared patients treated with coils (2 unilateral
and 21 bilateral) with 23 patients who received
conservative medical treatment. These patients were
followed for up to three months. The RESET study
reported an increase of 114.1% in FEV1 in patients
having ELVR-C and 13.5% in those receiving standard
medical care, showing a statistically significant
difference.[10] Slebos et al.[9] performed 28 ELVR-C
procedures in 16 patients (4 unilateral, 12 bilateral) and
observed improvements both in FEV1 a nd RV a fter a
six-month follow-up. In a multicenter study conducted
by Deslee et al.,[19] 34 patients were treated and followed
for up to 12 months. Those patients experienced
significant improvement in pulmonary functions (both
in FEV1 and RV). Hartman et al.[20] conducted a threemonth
follow-up study and followed 35 patients for
one year, 27 patients for two and 22 patients for three years. The patients showed a significant improvement
in FEV1 at the end of the first year. Forced expiratory
volume in one second decreased during the second
and third years, respectively, but remained higher
than the baseline values. The results in our study are
satisfactory both for functional and QoL parameters,
and seem to be in parallel with the studies mentioned
above.

In our study, postoperative complications were mild
and all events resolved with regular medical care, and
no noninvasive ventilatory support or ICU admissions
were required. Lower morbidity and mortality rates
are two of the major advantages of ELVR when
compared to LVRS. Being able to treat patients
with homogeneous emphysema is another significant
advantage of endobronchial coils when compared to not
only LVRS but also the other ELVR techniques, such
as valves. Our study exhibits that ELVR-C is effective
in both types of emphysema, either homogeneous or
heterogeneous.

There are currently several ELVR techniques in
use, endobronchial one-way valves being the most
commonly used in daily practice. These valves,
however, were designed for segmental and lobar airway
closure, and only work when there is no, or only very
limited, collateral ventilation.[21-23] As endobronchial
coils reduce the lung volume not by causing atelectasis
but by bending the airway and attached parenchyma,
their effect is independent of collateral ventilation,
thus patients having ELVR-C may have the advantage
of experiencing more pronounced benefits even if they
have incomplete fissures.[24]

This study has some limitations. The total number
of patients and the number of bilaterally treated
patients are relatively low, and also the follow-up
period can be considered as being short.

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